NCT02933853已完成1 期
This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Area under the serum insulin aspart concentration-time curve
研究概览
简要总结
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed
- •Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening
- •HbA1C below or equal to 9.5 % based on central laboratory analysis
排除标准
- •Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period
- •Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening
研究组 & 干预措施
Faster Aspart
Experimental
干预措施: Faster-acting insulin aspart (Drug)
Insulin Aspart
Active Comparator
干预措施: Insulin Aspart (Drug)
结局指标
主要结局
Area under the serum insulin aspart concentration-time curve
时间窗: From 0 to 30 minutes
次要结局
- Maximum glucose infusion rate(Within 0 to 12 hours after dosing)
- Maximum observed serum insulin aspart concentration(Within 0 to 12 hours after dosing)
- Area under the glucose infusion rate curve(From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing))
研究者
研究点 (1)
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